MAUDE Adverse Event Report: CYBERONICS PULSE GEN MODEL UNK; GENERATOR

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

An article titled ¿vagus nerve stimulation for intractable epilepsy: a retrospective bicentric cohort study of 101 patients operated on between 1999 and 2010¿ was published on 01/29/2016 which included adverse events involving 4 vns patients.One patient underwent vns explant surgery due to ¿intolerance¿.Two patients presented infection.The patients underwent explant of the vns system due to the infection.One patient had his/her vns device disabled due to side effects.No known surgical interventions for the treatment of the patient have occurred to date.Attempts to obtain additional information were unsuccessful to date.This manufacturer report captures the patient 1 who presented infection and underwent explant surgery.Manufacturer report # 1644487-2016-01614 involves the patient who underwent vns explant surgery due to ¿intolerance¿.Manufacturer report # 1644487-2016-01616 involves the patient 2 who presented infection and underwent explant surgery.Manufacturer report # 1644487-2016-01617 involves the patient who had his/her vns device disabled due to side effects.

• Brand Name: PULSE GEN MODEL UNK
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 5802159
• MDR Text Key: 49814581
• Report Number: 1644487-2016-01615
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention